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COPD重磅炸弹——勃林格新药Spiriva Respimat获批,将取代市场No.1药物

  1. COPD
  2. Spiriva
  3. 勃林格殷格翰
  4. 噻托嗅按
  5. 慢性阻塞性肺病

来源:生物谷 2014-09-26 11:53

Spiriva Respimat将成勃林格呼吸管线中的一枚重磅药物,该药采用吸入性气雾配方,将取代市面处方量第一的COPD药物Spiriva HandiHaler。

2014年9月26日讯 /生物谷BIOON/ --导读勃林格殷格翰是呼吸疾病领域的领导者,该公司开发的COPD新药Spiriva Respimat于2007年被FDA拒绝。之后开展了全球最大的COPD临床研究,证明了疗效和安全性。近日,FDA终于批准Spiriva Respimat,该药与COPD市场中处方量排名第一的药物Spiriva HandiHaler具有相同的成分,但前者的气雾配方具有舒适性及便利性优势,尤其将使初诊COPD患者群体受益。业界预测,Spiriva Respimat将取代Spiriva HandiHaler,成为COPD市场的领导者,并实现重磅销售。

勃林格殷格翰(Boehringer Ingelheim)近日宣布,FDA已批准Spiriva Respimat(tiotropium bromide,噻托嗅按)吸入气雾剂,作为一种长期的、每日一次的维持性药物,用于慢性阻塞性肺病(COPD,包括慢性支气管炎和肺气肿)支气管痉挛的治疗,以及减少COPD急性加重。Spiriva Respimat将为COPD提供一种重要的治疗选择,尤其是初诊COPD患者。

Spiriva Respimat具有与已上市药物Spiriva HandiHaler相同的活性成分(噻托溴铵粉吸入剂),在美国,Spiriva HandiHaler是处方量排名第一的COPD维持药物,勃林格表示,该药将继续作为COPD患者的一种治疗选择。Spiriva Respimat的开发,旨在不依赖空气快速通过吸入器的方式递送药物,而是通过一种缓慢移动的气雾递送定量的药物。勃林格计划于2015年1月将Spiriva Respimat推向市场。

FDA曾于2007年拒绝批准Spiriva Respimat,理由是安全性问题及缺乏疗效证据。此次,勃林格开展了迄今为止在COPD患者中开展的最大临床研究TIOSPIR,该项研究涉及17135例COPD患者,数据表明,Spiriva Respimat疗效媲美Spiriva HandiHaler。该项研究的领导者表示,Spiriva Respimat的气雾配方,尤其将使初诊COPD患者群体受益,与Spiriva HandiHaler干粉配方相比,气雾配方舒适性及便利性更好。

今年8月,FDA肺过敏药物咨询委员会(PADAC)也建议批准Spiriva Respimat。该委员会认为,Spiriva Respimat能够有效减少支气管痉挛和COPD急性加重,同时全因死亡方面无显著风险。

今年7月,FDA也批准了勃林格另一款基于Respimat气雾吸入器的COPD药物Striverdi Respimat。(生物谷Bioon.com)

本文系生物谷原创编译整理,欢迎转载!转载请注明来源并附原文链接。谢谢!

英文原文:Boehringer Ingelheim Announces FDA Approval of Spiriva? Respimat? (tiotropium bromide) Inhalation Spray for the Maintenance Treatment of COPD

RIDGEFIELD, Conn., Sept. 25, 2014 /PRNewswire/ -- Boehringer Ingelheim Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) approved Spiriva? Respimat? (tiotropium bromide) inhalation spray for the long-term, once-daily maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema and to reduce exacerbations in COPD patients. Boehringer Ingelheim anticipates SPIRIVA RESPIMAT to be available in January 2015.

SPIRIVA RESPIMAT provides a pre-measured amount of medicine in a slow-moving mist that helps patients inhale the medicine. SPIRIVA RESPIMAT was developed to actively deliver medication in a way that does not depend on how fast air is breathed in from the inhaler.

SPIRIVA RESPIMAT has the same active ingredient as Spiriva? HandiHaler? (tiotropium bromide inhalation powder), which is the number one branded prescription medication for COPD maintenance in the United States. SPIRIVA HandiHaler will continue to be available as a treatment option.

"SPIRIVA RESPIMAT offers a new choice between a mist and dry powder inhaler for tiotropium," said Sabine Luik, M.D., senior vice president, Medicine & Regulatory Affairs, Boehringer Ingelheim Pharmaceuticals, Inc. "Already approved in 85 countries around the world, SPIRIVA RESPIMAT reflects our scientific heritage as an industry leader in discovering and developing new treatment options for the COPD community."

The approval of SPIRIVA RESPIMAT is based on data from seven clinical trials in which 8,700 patients were treated with SPIRIVA RESPIMAT. One of these trials, TIOSPIR?, the largest clinical trial conducted to date in patients with COPD, collected data from more than 5,700 patients treated with SPIRIVA RESPIMAT and nearly 5,700 patients treated with SPIRIVA HandiHaler.

The most common side effects reported with SPIRIVA RESPIMAT include sore throat, cough, dry mouth and sinus infection.

"COPD is a chronic condition that requires highly individualized treatment for optimal disease management. It's essential to have multiple choices available for healthcare providers and patients," said Stephen Rennard, M.D., Professor, Internal Medicine, Division of Pulmonary, Critical Care, Sleep & Allergy, University of Nebraska Medical Center. "Each inhaler option has different features that a healthcare provider and patient might decide are more suitable for their specific situation."

The RESPIMAT is the platform inhaler for the Boehringer Ingelheim suite of inhaled bronchodilators, including approved and investigational therapies. SPIRIVA RESPIMAT is the third FDA-approved product delivered by the RESPIMAT, which is the only inhaler available in the U.S. that uses mechanical energy to generate a slow-moving mist to deliver the medication.

About Spiriva? Respimat? (tiotropium bromide) Inhalation Spray

Indication

SPIRIVA? RESPIMAT? (tiotropium bromide) Inhalation Spray is a prescription medicine used once every day (a maintenance medicine) to relax your airways and help keep them open. COPD includes chronic bronchitis, emphysema, or both.

SPIRIVA RESPIMAT also reduces the likelihood of COPD flare-ups (COPD exacerbations).

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